In August 2016, Stryker Corporation recalled several lots of its LFIT™ Anatomic CoCr V40™ Femoral Head, a component in many metal-on-metal hip replacements. According to Stryker, the company has received higher than expected complaints of taper lock failure with certain lots made before 2011.
There are a number of potential complications associated with the issue, including excessive metallic debris, component fracturing or disassociation, and insufficient range of motion, among other problems. These complications may cause serious side effects, including:
- Loss of mobility
- Adverse local tissue reaction
- Joint instability
- Broken bones around the components
- Leg length discrepancy
- Metallosis (metal poisoning)
- Pseudotumor (fluid buildup around the implant)
- Need for revision surgery
Many patients may experience symptoms soon after surgery, but symptoms can also occur years later. If you’re suffering from these health problems – or if you had or need revision surgery, you may be entitled to compensation.
Regulatory Action and Scope of the Problem
The U.S. Food and Drug Administration (FDA) posted a notice of the recall to their website on November 9, 2016 after similar regulatory actions in Canada, the United Kingdom, and Australia.
Additionally, while the LFIT V40™ Femoral Head can be a component of several Stryker hip systems, including the Accolade, Citation, Meridian, Exeter, Reliance, Definition, Restoration, Rejuvenate, and ABG II stems – the problem is not limited to Stryker. This component may also be used with other brands of hip replacements – making use of this recalled product more widespread.
3 Major Recalls
Stryker has recalled 3 hip replacement components due to product defects. Prior to the LFIT V40™ Femoral Head, the Rejuvenate and ABG II hip stem components were recalled in 2012. These products were prone to corrosion, resulting in metal debris becoming embedded in the tissue around the implant. Excessive metal debris can lead to metallosis, or metal poisoning that can eventually cause bone loss and severe tissue damage. Stryker has now paid over $1 Billion in settlements to those who suffered injuries from these products.
The LFIT™ Anatomic CoCr V40™ Femoral Head, Accolade, Citation, Meridian, Exeter, Reliance, Definition, Restoration, Rejuvenate, and ABG II are registered products of Stryker Corporation, its divisions, and other corporate affiliated entities.
Note: Any medical decision is important. Please consult your doctor before making any medical decision.